Duns Number:482661753
Device Description: PROWLER SELECT PLUS TIP MARKERS 2 TIPSHAPE 45 Infusion Catheter 2.8F (0.95mm) 2.3F (0.75mm PROWLER SELECT PLUS TIP MARKERS 2 TIPSHAPE 45 Infusion Catheter 2.8F (0.95mm) 2.3F (0.75mm) .021 Inch (0.5mm) 5cm 150cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .042 Inch (1.1mm)
Catalog Number
606S255FX
Brand Name
PROWLER SELECT
Version/Model Number
606-S255FX
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K021591
Product Code
KRA
Product Code Name
Catheter, continuous flush
Public Device Record Key
d7851070-73a6-461a-a0b6-db7231d88e89
Public Version Date
January 29, 2020
Public Version Number
5
DI Record Publish Date
June 30, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |